PROTON NEWS

FDA clears Mevion's small-footprint proton therapy device

It's been a long road for eight-year-old proton therapy start-up Mevion Medical Systems, formerly called Still River Systems. But the hard work appears to be paying off: the company has just earned U.S. marketing rights for a technology it claims could make the high-tech, and generally very capital-intensive, cancer-blasting technology more accessible to providers.

On Monday, the Littleton, Mass.-based company announced it received Food and Drug Administration 510 (k) clearance for its smaller-footprint proton therapy system, the Mevion S250.

Originally called the Monarch S250, the system comprises a superconducting synchrocyclotron that fires protons at energies up to 250 MeV to blast cancers. Unlike rival proton accelerators, the Mevion unit features a more compact design that's expected to lower the cost of setting up treatment centers for hospitals and radiation oncology groups, according to the company.

The high price-tag is one reason only 10 proton therapy centers are currently operating in the U.S. The newest center, a $160 million four-room facility made by for-profit proton chain ProCure, just opened in New Jersey this spring. However, other lower-cost proton technologies are also coming online. A McLaren Health Care center in Michigan that's scheduled to open later this year uses a ProTom International synchrotron, reported to have cost $50 million to build.

"FDA approval is a huge step forward for Mevion and for other lower cost compact machines on the horizon," Leonard Arzt, executive director of the National Association for Proton Therapy, an industry group, told DOTmed News by e-mail. "[It's] especially good news for patients. It provides added accessibility for cancer patients seeking the benefits of proton therapy. It certainly has all the makings of transforming the future of proton therapy."

First patients possibly treated this fall

Now that the device is cleared by the FDA, Mevion system users can begin treating patients as soon as their units are installed. This means the first patient could be treated this fall, according to a spokesman from Barnes-Jewish Hospital in St. Louis, where the first installation of a Mevion S250 unit began in October.

The hospital spokesman told DOTmed News in an e-mail that the one-room, $20 million Kling Center for Proton Therapy will start treating patients by the fourth quarter, and possibly as early as November 15. Once up and running, the center will treat 200 patients annually, the spokesman said.

Two other Mevion installations are also underway: one at Robert Wood Johnson University Hospital in New Brunswick, N.J. and another at Oklahoma University in Oklahoma City, Mevion said.

"Completing this very important milestone is a testament to the maturity of the Mevion organization and its ability to manufacture, install and support a safe and effective product," Mevion's CEO Joseph Jachinowski said in a statement.